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Quality Systems Specialist I

Company: Starkey Labs
Location: Eden Prairie
Posted on: January 9, 2022

Job Description:

Starkey Hearing Technologies is a privately held, global hearing technology company headquartered in Eden Prairie, Minnesota. Founded -in 1967, Starkey is known for its innovative design, development and distribution of comprehensive digital hearing systems. Starkey is the only American-owned provider of hearing technologies. The company has more than 6000 employees globally, operates 26+ facilities and does business in more than 100 markets worldwide. - Starkey's product Livio AI was named to TIME's list of the 100 Best Inventions of 2019.
Here's a video about how Starkey is redefining the hearing healthcare industry, which features 13 employees: - https://www.youtube.com/watch?v=Rujbz9DCoI8
This position is responsible for verifying and maintaining compliance with Federal and International regulations, and for improving QMS (quality management system) through system certification (ISO 13485), as well as meeting global QMS requirements.
Assist Manager of Quality to manage global CAPA system and drive continuous improvements.
Ability to manage HQ CAPA Meetings; Record all meeting notes and actions;
Manage CAPA database: Update CAR status and reporting agenda; Follow up with pending CARs;
Work with global facilities to reinforce CAPA system implementation.
Lead internal audit activities per ISO 13485, 21CFR820 and other applicable QMS requirements.
Audit the quality system on a periodic basis to verify compliance.
Track and support completion of all action items resulting from internal audits.
Provide education for the ISO 13485.
Via QMS training ensure impacted employees are trained to appropriate quality system documents.
Ensure governance and maintenance of the Applicable Standards List is in place and adhered to.
Comply with FDA 21CFR820 rules, regulations and guidelines.
Maintain GMP's (Good Manufacturing Practices) according to FDA guidelines.
Assist external audit investigators with information collection and interpretation during audits.
Starkey employees are responsible for understanding, implementing, and maintaining the Starkey Quality Policy within their work area.--- All employees have the responsibility to proactively identify areas for improvement and the authority to bring these Quality System improvement ideas to the attention of their supervisor and/or a Quality individual.
Exercise of authority or supervision over others:
Responsible for monitoring the effectiveness and professionalism of internal auditors as it relates to future participation on the audit roundtable. May provide feedback to the auditors' managers upon request.
Four-year degree required.
Education in Engineering or Science preferred.
Knowledge of GMP and FDA 21CFR820 required.
Knowledge of ISO 13485 criteria preferred
Knowledge of MDD and EU MDR preferred.
Skills & Abilities
Ability to lead group meetings/presentations required.
Ability to perform system thinking
Communicate with internal stakeholders and regulatory authorities
Critical thinking and problem solving
Good attention to detail


Keywords: Starkey Labs, Eden Prairie , Quality Systems Specialist I, Other , Eden Prairie, Minnesota

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